U.S. patent application number 15/779383 was filed with the patent office on 2020-05-28 for cloud based pulse oximetry system and method including optional headband component.
This patent application is currently assigned to Serenium, Inc.. The applicant listed for this patent is Serenium, Inc.. Invention is credited to David Gozal, David Rosen, Michael Cory Zwerling.
Application Number | 20200163599 15/779383 |
Document ID | / |
Family ID | 58289777 |
Filed Date | 2020-05-28 |
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United States Patent
Application |
20200163599 |
Kind Code |
A1 |
Gozal; David ; et
al. |
May 28, 2020 |
CLOUD BASED PULSE OXIMETRY SYSTEM AND METHOD INCLUDING OPTIONAL
HEADBAND COMPONENT
Abstract
A cloud based pulse oximetry system and method is provided that
incorporates both a software and hardware component. The hardware
component includes a limited use pulse oximetry probe having an
energy source and data transmitting capabilities. The probe houses
a light source and a light detector that compare and calculate the
differences in the oxygen-rich versus oxygen-poor hemoglobin in the
body part to which, it is attached. Data from the probe is
collected, analyzed, and communicated using a cloud based computing
system. The system may be used for collecting and analyzing pulse
oximetry data for any medical need such as diagnosis of obstructive
sleep apnea.
Inventors: |
Gozal; David; (Chicago,
IL) ; Rosen; David; (Glencoe, IL) ; Zwerling;
Michael Cory; (Palo Alto, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Serenium, Inc. |
Palo Alto |
CA |
US |
|
|
Assignee: |
Serenium, Inc.
Palo Alto
CA
|
Family ID: |
58289777 |
Appl. No.: |
15/779383 |
Filed: |
September 19, 2016 |
PCT Filed: |
September 19, 2016 |
PCT NO: |
PCT/US2016/052479 |
371 Date: |
May 25, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62219877 |
Sep 17, 2015 |
|
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|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G16H 40/63 20180101;
A61B 5/6814 20130101; A61B 5/1114 20130101; A61B 5/0022 20130101;
A61B 5/14551 20130101; A61B 5/1126 20130101; G16H 40/67 20180101;
A61B 5/4818 20130101; A61B 5/6898 20130101 |
International
Class: |
A61B 5/1455 20060101
A61B005/1455; A61B 5/00 20060101 A61B005/00; G16H 40/67 20180101
G16H040/67; G16H 40/63 20180101 G16H040/63 |
Claims
1. A wireless cloud computing based pulse oximeter system and
method as shown and described, in any configuration and in any
combination.
Description
FIELD OF THE INVENTION
[0001] This invention relates to methods, systems, and apparatus
for using pulse oximetry to measure blood oxygen saturation.
Specifically, it relates to such methods, systems, and apparatus
using disposable wireless cloud based pulse oximetry systems to
identify and diagnose potential obstructive sleep apnea in a
patient.
BACKGROUND OF THE INVENTION
[0002] Obstructive sleep apnea-hypopnea syndrome (OSAHS) is
characterized by repetitive occlusion of the upper airway during
sleep, causing intermittent cessations of breathing (apneas) or
reduction in airflow (hypopneas). Events of apnea are accompanied
by hypoxemia and bradycardia. They are often terminated in
arousals, and the resulting sleep fragmentation can lead to
excessive daytime sleepiness. As a result, OSAHS has been pointed
out as a major public health concern. Additionally, long-term
effects are related to the cardiovascular system, including
hypertension, arrhythmias, congestive heart failure and
cerebrovascular disease.
[0003] The "gold standard" approach to diagnose OSAHS is overnight
polysomnography (PSG). However, PSG has several limitations since
it is both complex and costly due to the high number of
physiological signals that need to be recorded. It must be
performed in a special sleep unit and under supervision of a
trained technician. PSG monitors different physiological recordings
such as electrocardiogram (ECG), electroencephalogram (EEG),
electrooculogram (EOG), electromyogram (EMG), oxygen saturation,
abdominal ventilatory effort and snoring. These recordings must be
subsequently analyzed by a medical expert to obtain a final
diagnosis. Despite its high diagnostic performance, PSG presents
some drawbacks since it is complex, expensive and time-consuming.
Additionally, all the PSG signals need offline inspection in order
to derive the apnea-hypopnea index (AHI), which is used to
establish whether OSAHS is present and its severity. As a result,
research recently has focused on the development of alternative and
simpler diagnostic techniques, such us the use of medical systems
based on nocturnal pulse oximetry. An interesting approach is the
analysis of single-channel sleep-related recordings, which reduces
cost and complexity. In this regard, automated processing of
oximetry signals is a promising alternative due to its reliability,
simplicity, and suitability.
[0004] Nocturnal pulse oximetry allows to monitor respiratory
dynamics during sleep by measuring blood oxygen saturation (SpO2).
This recording provides useful information about OSAHS. Events of
apnea are characterized by a decrease in the SpO2 value, which
reflects airflow reduction and hypoxemia. Subsequently, respiration
is restored and the saturation value increases until its baseline
level. As a result, SpO2 signals from OSAHS patients tend to be
more unstable than those from control subjects due to the
recurrence of apneas during sleep. This different behavior can be
exploited to diagnose OSAHS.
[0005] Although many advances have been made utilizing pulse
oximetry to diagnose OSAHS, known and currently utilized probes can
be cumbersome, expensive and not as accessible to patients for
usage. There remains a need for a pulse oximetry system that is
more approachable, less expensive, and available for usage in a
variety of situations. The system of the present invention,
accordingly, contemplates a lower cost system that uses a
disposable oximetry probe in conjunction with a cloud based
computing system to measure, analyze, and communicate data and
results in a more efficient and economical manner.
SUMMARY OF THE INVENTION
[0006] While the invention may be susceptible to embodiment in
different forms, there is shown in the drawings, and herein will be
described in detail, specific embodiments with the understanding
that the present disclosure is to be considered an exemplification
of the principles of the invention, and is not intended to limit
the invention to that as illustrated and described herein.
[0007] While preferred embodiments of the present invention are
shown and described, it is envisioned that those skilled in the art
may devise various modifications of the present invention without
departing from the spirit and scope of the appended claims.
[0008] With reference to Diagram 1, the system of the present
invention contemplates the capturing of vital sensor data and
analyzing data utilizing a limited use and/or disposable wireless
probe and a cloud based computing system to capture, analyze, and
transmit/communicate the data and analytical results. The system
contains hardware and software components as will be described
herein.
[0009] A. Hardware
[0010] Pulse oximetry is a procedure used to measure the oxygen
level (or oxygen saturation) in the blood. It is considered to be a
noninvasive, painless, general indicator of oxygen delivery to the
peripheral tissues (such as the finger, earlobe, or nose). A
clip-like device called a probe is placed on a body part to measure
the blood that is still carrying or is saturated with oxygen. The
probe typically houses a light source, a light detector, and may
include a microprocessor, which compares and calculates the
differences in the oxygen-rich versus oxygen-poor hemoglobin. A
typical probe has one side having a light source with two different
types of light, infrared and red, which are transmitted through the
body part, such as a finger, to the light detector side of the
probe. The oxygen-rich hemoglobin absorbs more of the infrared
light and the hemoglobin without oxygen absorbs more of the red
light.
[0011] For the present invention, a pulse oximeter probe is
utilized that is placed on the fingertip (in multiple sizes, small,
medium, large adult, and pediatric/infant sizes) or another part of
the human body (such as ear, toe or forehead) which captures blood
oxygen levels and heart rate or other vital signs. Preferably, the
probe is designed for limited use and is a disposable device having
its own energy source and sensor mechanism(s) (as are known in the
art) to measure blood oxygen levels. The probe contemplated for use
with the present invention also preferably does not include a
microprocessor but rather relies on a cloud computing system to
store and analyze the data.
[0012] Also, the probe utilized with the present invention
preferably emits a wireless transmission signal of the data being
monitored using Bluetooth, radio frequency or other suitable and
known wireless transmission method. These data readings are then
preferably captured by a mobile device such as a phone or tablet or
the like and uses the supporting application or software residing
on such mobile device to analyze and interpret the data. This data
is then transmitted and uploaded into a cloud computing system for
data storage and analysis. Such data are preferably securely
accepted with a unique identifier or "hand-shake" procedure.
[0013] Depending on the energy source or battery life, the
disposable device can be contemplated for single usage or for
multiple uses based on a limited energy or battery source in the
unit, and then disposed or recycled.
[0014] Upon initial use of the probe, the probe preferably emits a
test transmission signal using Bluetooth, radio frequency or other
wireless transmission to insure authentication and secure
connection with the cloud-based system. The supporting application
or software for the mobile device will preferably confirm this
initialization process or pre-test operations and if needed
identify trouble shooting procedures.
[0015] A.1 Optional Headband Component
[0016] The probe optionally may at least in part comprise a
headband component and related system. The headband system, as
shown in Diagram 2, may also generally include a system for
capturing vital sensor data from the wearer and may analyze the
data using a magnet with a wireless sensor positioned on the
forehead and chin to deliver clinically relevant information.
[0017] Known prior art devices, from which the present invention
builds from, include a distance measuring device comprising an
emitter and a receiver. The prior art emitter is preferably
arranged to produce a magnetic field with a resonant circuit having
a resonant frequency. The prior art receiver is preferably arranged
to pick up at the resonant frequency the magnetic field emitted by
the emitter and convert the strength of the magnetic field picked
up into a first signal having an energy value. The prior art
emitter is preferably arranged to produce the magnetic field
intermittently with each emission having a predetermined energy.
The prior art receiver is preferably connected to a detector
arranged to determine a distance measurement signal representing
the distance between the emitter and the receiver.
[0018] According to these prior art devices, the strength of the
magnetic field picked up gives a measurement of the distance
between the emitter and the receiver and can in this way be used to
measure a distance between two points. To obtain this distance the
first signal is amplified selectively. One drawback of the known
devices is that they are not adapted to reliably and accurately
measure distances of more than a few centimeters without having to
use a high-strength magnetic field. Moreover the selective
amplification of the first signal is not stated precisely, such
that it does not allow an accurate determination of the distance,
in particular when the first signal comprises an amount of noise
and interference. For this reason earlier known devices have been
found to be unreliable to measure movements of the mouth of a
living being in applications where high resolution is required.
This is because high-power magnetic fields are not suitable to be
used frequently on living beings without having a detrimental
effect on the health of that living being.
[0019] U.S. Pat. No. 8,203,330 discloses a distance measuring
device that is capable of measuring distances very accurately, in
particular on the human body, without having to use a value of
magnetic field that would be too strong for the human body that
addresses some of the shortcomings of the prior art systems. The
'330 patent is issued to Nomics and the present applicant Serenium
Inc. has obtained an exclusive license to practice the invention in
the United States together with any Serenium improvements. As such,
the entirety of U.S. Pat. No. 8,203,330 is incorporated herein by
reference.
[0020] Specifically, the '330 device is characterized in that the
detector is arranged to determine the distance measurement signal
by correlation of the first signal with a second predetermined
signal having a waveform representative of a signal to be picked up
by the receiver. The second signal preferably comprises a time
window having a predetermined duration and comprising at least an
initial sub-period, an intermediate sub-period and a final
sub-period. The second signal preferably being an alternating
signal synchronized with the first signal and whereof the amplitude
is attenuated during the initial and final periods and
substantially at a maximum during the intermediate period. The use
of an alternating signal whereof the amplitude is attenuated during
the initial and final sub-periods makes it possible to considerably
reduce the noise and interference appearing in frequency ranges far
from the resonant frequency. The fact that the amplitude is
substantially at a maximum during the intermediate period, that is
to say where the first signal reaches its maximum value, makes it
possible to considerably reduce the noise and interference in the
frequency ranges very close to the resonant frequency whilst making
maximum use of the amplitude of this signal during this
intermediate sub-period and therefore to be able to work with
magnetic fields whereof the power remains low and therefore without
damage to the human body. The '330 device finds its application in
detectors for sleep disorders or other forms of illness.
[0021] A first preferential embodiment of the '330 device is
characterized in that the detector is arranged to implement the
correlation by multiplication and integration with the second
signal, which second signal is formed by said waveform representing
a sinusoidal waveform in synchronization with the first signal
itself multiplied by a Tukey window with reduced taper factor. This
allows rejection of noise and interference outside the detection
frequency.
[0022] A second preferential embodiment of the '330 device
according to the invention is characterized in that the emitter is
housed in a case and arranged to produce said magnetic field
outside said case with a power less than 1 mTesla, preferably less
than 1 .mu.Tesla. This embodiment is particularly adapted to the
human body. A sleep disorder detector according to the '330 system
is characterized in that the device is mounted on a support
arranged to be applied onto the head of a living being so as to
measure movements of the mouth.
[0023] The headband system of the present invention builds on the
prior art systems described above in this section and addresses
some of the shortcomings thereof. Specifically, and with reference
to Diagram 2, the present headband system comprises many of the
hardware and software components of the '330 patent, but has been
improved and advantageously reconfigured for consumer or user
benefits and as so as to fit into an embodiment of a headband
system configuration as shown in Diagram 2. In general, the system
preferably has at least two variations: a basic headband system and
a system with an optional "built in" pulse oximeter probe.
[0024] In the present invention, the main distance measuring unit
is integrated or attached to a headband to be worn over a person's
forehead. There is an attaching magnet unit that sits on the chin
and can be either hard wired or wirelessly connected (via
Bluetooth, radio frequency, or other wireless transmission
configurations) with the main forehead unit.
[0025] The main unit contains comprises an emitter and a receiver
placed at a distance of the headband and the chin magnet. The
emitter comprises an induction coil preferably connected in series
with a capacitor, whilst in the receiver the induction coil and the
capacitor are preferably connected in parallel. The emitter and
receiver may be connected by means of a cable to a conditioning and
measuring unit. The unit comprises a detector and an energizing
circuit. The sensors use the property that a resonant circuit has
of energizing another one tuned to the same frequency, through
their mutual induction coil. The use of resonant circuits rather
than simple induction coils significantly improves both the
performance of the energizing circuit and the sensitivity of the
sensor. The use of simultaneous connection of the emitter and the
receiver to the same electronic circuit makes it possible to
simplify the device by avoiding synchronization errors.
[0026] The main unit also may comprise a pulse oximeter sensor that
attaches around the user's forehead through the headband,
appropriate pulse oximeter system boards, and associated components
and devices.
[0027] The main unit preferably comprises Bluetooth or radio
frequency or other wireless transmission capabilities for wireless
connections captured by a mobile device like a phone or other
similar device and uses the supporting App or Software residing on
such mobile device. Similar to the other oximeter probe
configurations described above, the data from the pulse oximeter is
preferably transmitted into a cloud computing system for data
storage and analysis, where the data are securely accepted with a
unique identifier or hand-shake procedure.
[0028] There may be Bluetooth connectivity between the main
forehead unit and the magnet on the chin or, as described above, a
hard wire connection between these two components. There may also
be a USB plug for hard wire connectivity and potential
recharging.
[0029] This system could be a disposable unit with a single usage
or for multiple uses based on a limited energy or battery source in
the unit, and then disposed or recycled. Alternatively, it could
also be rechargeable.
[0030] Upon initial use of the headband system, the main unit
preferably emits a test transmission signal using Bluetooth, radio
frequency or other wireless transmission to insure authentication
and secure connection with the cloud-based system. The supporting
App or Software for the mobile device will confirm this
initialization process or pre-test operations and if needed
identify trouble shooting procedures.
[0031] B. Analytics Software
[0032] Software configured or known in the art is used with the
data that is collected and transmitted from the probe to the cloud
based system (or server based system) for analysis and is more
preferably encrypted and HIPAA compliant. It should be appreciated
that the software preferably utilizes and includes one or more of
method algorithms known in the art, data analytical tools,
communications capabilities to communicate the analysis and/or raw
data results, and neural diagnostic network systems.
* * * * *